Isovox is indicated for the treatment of adult (> 18 years of age) with mild to moderate and severe infections caused by susceptible strains of microorganisms.
- Acute maxillary sinusitis
- Acute bacterial exacerbation of chronic bronchiti
- Community acquired pneumonia
- Complicated urinary tract infection.
- Uncomplicated skin & soft tissue infection.
- Acute pyelonephritis caused by Ecoli.
Composition: Isovox 500 tablet: Each film coated tablet contains Levofloxacin Hemihydrate USP 512.469 mg equivalent to Levofloxacin 500 mg.
Therapeutic Class: Antibiotic
Generic Name: Levofloxacin USP
Pharmacology: Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone derivative antibacterial agent for oral administration. Chemically Levofloxacin is a chiral fluorinated carboxyquinolone. It is active against both Gram-positive and Gram-negative bacteria. Like all quinolones, it functions by inhibiting the DNA gyrase and topoisomerase IV. Topoisomerase I which is necessary to separate DNA that has been replicated (doubled) prior to bacterial cell division.
Dose & administration:
Acute maxilliary sinusitis: 500 mg once daily for 10-14 days.
Acute bacterial exacerbation of chronic bronchitis: 250-500 mg daily for 7-10 days
Community acquired pneumonia: 500 mg once or twice daily for 7-14 days.
Complicated urinary tract infection: 250 mg daily for 7-10 days.
Uncomplicated skin & soft tissue infections: 250 mg daily or 500 mg once/twice daily for 7-14 days.
Acute pyelonephritis: 250 mg once daily for 7-10 days.
Contraindication: Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, Quinolone antimicrobial agents or any other components of the drug.
Warning & Precaution: While taking Levofloxacin adequate amount of water should be drunk to avoid concentration form of urine. Dose adjustment should be exercise during Levofloxacin ingestion in presence of renal insufficiency.
a) Common: Levofloxacin is generally well tolerated. Common side effect includes nausea, vomiting, diarrhea, abdominal pain, flatulence.
b) Rare: Side effects that may be seen very rarely include photo toxicity, anxiety, tremor, depression, serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).
Use in pregnancy and Lactation: Levofloxacin is not recommended for use in during pregnancy or nursing mother. As the effect on the pregnant woman or nursing woman are unknown.
Use in children & adolescents:
Not recommended for children.
a) With medicine: Levofloxacin should not co-administrate with Antacid or Iron, these can reduce the absorption of levofloxacin.
b) With Food and others: Levofloxacin should not co-administrate with Milk and yogurt, these can decrease the absorption of Levofloxacin.
Overdose: Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
Storage: Store below 30°C, protected from light & moisture.
Keep away from the reach of the children
Packing: Isovox 500 tablet: Each Box containing 2 x10’s tablets in Alu-PVC blister pack.